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Pilot Study for Collecting Data on Liver Adipose Content in Adults by Ultrasound Attenuation and Scattering Imaging and MRI Proton-density

NCT07189650 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-09-24

No results posted yet for this study

Summary

The aim of this single-center, prospective, pilot study is to acquire data on liver adipose content in a population of adult patients affected by MASLD (Metabolic Dysfunction-Associated Liver Disease).

Ultrasound attenuation (QAI) and scattering (QSI) imaging parameters will be acquired.

Fat percentage parameters, obtained from magnetic resonance imaging with proton density technique (MRI-PDFF), will be acquired as well and they will be considered as reference method and gold standard.

The study is initiated for exploratory and research purposes. The study will enroll 30 consecutive, non-vulnerable adult participants who are scheduled to undergo upper abdominal ultrasound (Intervention A) as part of their standard clinical evaluation for the diagnosis and/or management of steatotic liver disease (SLD).

Eligible participants will be invited to provide informed consent to undergo an additional, non-invasive imaging procedure (Intervention B), consisting of magnetic resonance imaging with proton density fat fraction (MRI-PDFF) quantification

Conditions

  • Metabolic Dysfunction-Associated Liver Disease

Interventions

DEVICE

MRI

Proton Density Fat Fraction Magnetic Resonance Imaging (MRI-PDFF )

Sponsors & Collaborators

  • Esaote S.p.A.

    lead INDUSTRY

Principal Investigators

  • Matteo Garcovich, MD, PhD · UOSD Ecografia Diagnostica e Interventistica - Fondazione Policlinico Universitario Gemelli IRCCS, Rome (Italy)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2026-03-31
Completion
2026-04-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07189650 on ClinicalTrials.gov